Time course of any treatment benefit [ Time Frame: 51 weeks post-injection ] [ Designated as safety issue: No ]

Enrollment:

21

Study Start Date:

October 2008

Primary Completion Date:

June 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Biological: Autologous cultured dermal and epidermal cells

A piece of occipital scalp is taken from the subject. The epidermal and dermal cells from this tissue are expanded in culture. The cells are then harvested and, for certain types of product, combined. These cells are then injected into the balding area of the scalp of the original subject.

Eligibility

Ages Eligible for Study:

18 Years to 65 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Male and female volunteers 18 to 65 years old, inclusive

Hair loss consistent with ≥ Grade III-Vertex, IV, VA, V, and VI, based on Norwood-Hamilton Scale providing there is bridging of hair in the anterior edge of the vertex circle.

Have no clinically significant disease or abnormal laboratory results taken at the screening visit.

Exclusion Criteria:

Known sensitivity to DMEM/F-12 or any component of the study material.

Known hypersensitivity to clindamycin hydrochloride, amphotericin B or streptomycin sulfate.

Subjects who have used minoxidil, or any oral or topical medication including over the counter and herbal medications for the treatment of hair loss within 6 months of study screening, or finasteride or dutasteride within 12 months of study screening.

A history of drug or alcohol abuse within 1 year of study enrollment.

Clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator.

Any clinically significant abnormal laboratory parameters.

A positive result at screening for human immunodeficiency virus (HIV 1 or 2), Hepatitis B or C, HTLV I/II.

Dermatologic condition in donation and/or study areas.

Prior surgery in the treatment area.

Insufficient hair or scarring in the donor area that might impact cell growth.

Any disease or condition (medical or surgical) that, in the opinion of the investigator, might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system function; or any condition that would place the subject at increased risk.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01451021